{
"NDC": [
{
"NDCCode": "65923-349-25",
"PackageDescription": "25 PACKET in 1 CARTON (65923-349-25) > 1 SWAB in 1 PACKET",
"NDC11Code": "65923-0349-25",
"ProductNDC": "65923-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uec Medical Insect Sting Relief",
"NonProprietaryName": "Isopropyl Alcohol, And Benzocaine",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160425",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "BENZOCAINE; ISOPROPYL ALCOHOL",
"StrengthNumber": ".06; .7",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-10-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "65923-349-10",
"PackageDescription": "100 PACKET in 1 CARTON (65923-349-10) > 1 SWAB in 1 PACKET",
"NDC11Code": "65923-0349-10",
"ProductNDC": "65923-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uec Medical Insect Sting Relief",
"NonProprietaryName": "Isopropyl Alcohol, And Benzocaine",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160425",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "BENZOCAINE; ISOPROPYL ALCOHOL",
"StrengthNumber": ".06; .7",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-10-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "65923-136-25",
"PackageDescription": "20 mg in 1 POUCH (65923-136-25)",
"NDC11Code": "65923-0136-25",
"ProductNDC": "65923-136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nu Pore Acne",
"NonProprietaryName": "Salicyilc Acid",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131204",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".05",
"StrengthUnit": "mg/100mg",
"Status": "Deprecated",
"LastUpdate": "2017-07-11"
},
{
"NDCCode": "65923-345-25",
"PackageDescription": "25 POUCH in 1 BOX (65923-345-25) > 3 g in 1 POUCH",
"NDC11Code": "65923-0345-25",
"ProductNDC": "65923-345",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uec Medical Bzk Antiseptic Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160219",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Directions: 1 clean the affected area, 2 apply a small amount of this product on the area 1 to 3 times daily, 3 may be covered with sterile bandage, 4 if bandaged let dry first."
},
{
"NDCCode": "65923-584-25",
"PackageDescription": "30 VIAL, SINGLE-USE in 1 BOX (65923-584-25) > .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "65923-0584-25",
"ProductNDC": "65923-584",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Care Single-use Eye",
"NonProprietaryName": "Polyethylene Glycol 400, And Propylene Glycol",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160328",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
"StrengthNumber": "4; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "12546-349-25",
"PackageDescription": "25 LOZENGE in 1 PACKAGE (12546-349-25) ",
"NDC11Code": "12546-0349-25",
"ProductNDC": "12546-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Halls",
"ProprietaryNameSuffix": "Sugar Free Mentho-lyptus",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20191206",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Mondelez Global LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "2.7",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20191206",
"SamplePackage": "N"
},
{
"NDCCode": "61703-349-36",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61703-349-36) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "61703-0349-36",
"ProductNDC": "61703-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irinotecan Hydrochloride",
"NonProprietaryName": "Irinotecan Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077915",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "IRINOTECAN HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080227",
"SamplePackage": "N",
"IndicationAndUsage": "Irinotecan Hydrochloride Injection, USP is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan Hydrochloride Injection, USP is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.",
"Description": "Irinotecan Hydrochloride Injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan Hydrochloride Injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP and Water for Injection, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan Hydrochloride Injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. The chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate. Its empirical formula is C33H38N4O6∙HCl∙3H2O and molecular weight is 677.19. It is slightly soluble in water and organic solvents. Its structural formula is as follows."
},
{
"NDCCode": "62157-349-01",
"PackageDescription": "25 kg in 1 DRUM (62157-349-01)",
"NDC11Code": "62157-0349-01",
"ProductNDC": "62157-349",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mebendazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20161012",
"EndMarketingDate": "20170804",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp",
"SubstanceName": "MEBENDAZOLE",
"StrengthNumber": "24.75",
"StrengthUnit": "kg/25kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20170804"
},
{
"NDCCode": "63323-349-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-25) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-01) ",
"NDC11Code": "63323-0349-25",
"ProductNDC": "63323-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipenem And Cilastatin",
"NonProprietaryName": "Imipenem And Cilastatin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090577",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "IMIPENEM; CILASTATIN SODIUM",
"StrengthNumber": "250; 250",
"StrengthUnit": "mg/20mL; mg/20mL",
"Pharm_Classes": "Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120103",
"SamplePackage": "N",
"IndicationAndUsage": "Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: : 1 Lower respiratory tract infections. ( 1.1) , 2 Urinary tract infections. ( 1.2) , 3 Intra-abdominal infections. ( 1.3) , 4 Gynecologic infections. ( 1.4) , 5 Bacterial septicemia. ( 1.5) , 6 Bone and joint infections. ( 1.6) , 7 Skin and skin structure infections. ( 1.7) , 8 Endocarditis. ( 1.8) .",
"Description": "Imipenem and Cilastatin for Injection, USP (I.V.) (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP (I.V.) is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C12H17N3O4SH2O, and its structural formula is:. Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z)-7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is. Imipenem and Cilastatin for Injection, USP (I.V.) is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. [see How Supplied/ Storage and Handling ( 16.1).] Each Imipenem and Cilastatin for Injection, USP (I.V.) 250 mg/250 mg vial contains imipenem USP 250 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 250 mg cilastatin and each 500 mg/500 mg vial contains imipenem USP 500 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 500 mg cilastatin. In addition, the 250 mg/250 mg vial contains 10 mg of sodium bicarbonate and the 500 mg/500 mg vial contains 20 mg of sodium bicarbonate. The sodium content of the 250 mg/250 mg vial is 18.8 mg (0.8 mEq) and the sodium content for the 500 mg/500 mg vial is 37.5 mg (1.6 mEq). Solutions of Imipenem and Cilastatin for Injection, USP (I.V.) range from colorless to yellow. Variations of color within this range do not affect the potency of the product."
},
{
"NDCCode": "63323-349-93",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-93) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-21) ",
"NDC11Code": "63323-0349-93",
"ProductNDC": "63323-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipenem And Cilastatin",
"NonProprietaryName": "Imipenem And Cilastatin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090577",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "IMIPENEM; CILASTATIN SODIUM",
"StrengthNumber": "250; 250",
"StrengthUnit": "mg/20mL; mg/20mL",
"Pharm_Classes": "Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120103",
"SamplePackage": "N",
"IndicationAndUsage": "Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: : 1 Lower respiratory tract infections. ( 1.1) , 2 Urinary tract infections. ( 1.2) , 3 Intra-abdominal infections. ( 1.3) , 4 Gynecologic infections. ( 1.4) , 5 Bacterial septicemia. ( 1.5) , 6 Bone and joint infections. ( 1.6) , 7 Skin and skin structure infections. ( 1.7) , 8 Endocarditis. ( 1.8) .",
"Description": "Imipenem and Cilastatin for Injection, USP (I.V.) (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP (I.V.) is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C 12H 17N 3O 4SH 2O, and its structural formula is:. Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z)-7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C 16H 25N 2O 5SNa, and its structural formula is:. Imipenem and Cilastatin for Injection, USP (I.V.) is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. [see How Supplied/ Storage and Handling ( 16.1).] Each Imipenem and Cilastatin for Injection, USP (I.V.) 250 mg/250 mg vial contains imipenem USP 250 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 250 mg cilastatin and each 500 mg/500 mg vial contains imipenem USP 500 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 500 mg cilastatin. In addition, the 250 mg/250 mg vial contains 10 mg of sodium bicarbonate and the 500 mg/500 mg vial contains 20 mg of sodium bicarbonate. The sodium content of the 250 mg/250 mg vial is 18.8 mg (0.8 mEq) and the sodium content for the 500 mg/500 mg vial is 37.5 mg (1.6 mEq). Solutions of Imipenem and Cilastatin for Injection, USP (I.V.) range from colorless to yellow. Variations of color within this range do not affect the potency of the product."
},
{
"NDCCode": "63323-349-94",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-94) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-41) ",
"NDC11Code": "63323-0349-94",
"ProductNDC": "63323-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipenem And Cilastatin",
"NonProprietaryName": "Imipenem And Cilastatin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090577",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "IMIPENEM; CILASTATIN SODIUM",
"StrengthNumber": "250; 250",
"StrengthUnit": "mg/20mL; mg/20mL",
"Pharm_Classes": "Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120103",
"SamplePackage": "N",
"IndicationAndUsage": "Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: : 1 Lower respiratory tract infections. ( 1.1) , 2 Urinary tract infections. ( 1.2) , 3 Intra-abdominal infections. ( 1.3) , 4 Gynecologic infections. ( 1.4) , 5 Bacterial septicemia. ( 1.5) , 6 Bone and joint infections. ( 1.6) , 7 Skin and skin structure infections. ( 1.7) , 8 Endocarditis. ( 1.8) .",
"Description": "Imipenem and Cilastatin for Injection, USP (I.V.) (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP (I.V.) is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C12H17N3O4SH2O, and its structural formula is:. Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z)-7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is:. Imipenem and Cilastatin for Injection, USP (I.V.) is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. [see How Supplied/ Storage and Handling ( 16.1).] Each Imipenem and Cilastatin for Injection, USP (I.V.) 250 mg/250 mg vial contains imipenem USP 250 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 250 mg cilastatin and each 500 mg/500 mg vial contains imipenem USP 500 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 500 mg cilastatin. In addition, the 250 mg/250 mg vial contains 10 mg of sodium bicarbonate and the 500 mg/500 mg vial contains 20 mg of sodium bicarbonate. The sodium content of the 250 mg/250 mg vial is 18.8 mg (0.8 mEq) and the sodium content for the 500 mg/500 mg vial is 37.5 mg (1.6 mEq). Solutions of Imipenem and Cilastatin for Injection, USP (I.V.) range from colorless to yellow. Variations of color within this range do not affect the potency of the product."
},
{
"NDCCode": "75839-349-99",
"PackageDescription": "25 kg in 1 DRUM (75839-349-99)",
"NDC11Code": "75839-0349-99",
"ProductNDC": "75839-349",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Enrofloxacin Hcl",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "ENROFLOXACIN",
"StrengthNumber": "5",
"StrengthUnit": "kg/5kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "65923-005-54",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (65923-005-54) > 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "65923-0005-54",
"ProductNDC": "65923-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Care Childrens Decongestant Nose Drops",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "NASAL",
"StartMarketingDate": "20120110",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "UNITED EXCHANGE CORP",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Directions (Nasal use only): 1 children 2 to under 6 years (with adult supervision): 2 to 3 drops into each nostril, not more often than every 4 hours , 2 children under 2 years of age: Consult a physician."
},
{
"NDCCode": "65923-144-57",
"PackageDescription": "1 TUBE in 1 CARTON (65923-144-57) / 57 g in 1 TUBE",
"NDC11Code": "65923-0144-57",
"ProductNDC": "65923-144",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Care Muscle And Joint",
"NonProprietaryName": "Menthol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191023",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "25",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191023",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 use only as directed, 2 adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily, 3 children under 12 years of age: ask a doctor."
},
{
"NDCCode": "0480-7062-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-7062-56) ",
"NDC11Code": "00480-7062-56",
"ProductNDC": "0480-7062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209801",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250529",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake."
},
{
"NDCCode": "0480-7063-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-7063-56) ",
"NDC11Code": "00480-7063-56",
"ProductNDC": "0480-7063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209801",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250529",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake."
},
{
"NDCCode": "0480-7065-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-7065-56) ",
"NDC11Code": "00480-7065-56",
"ProductNDC": "0480-7065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209801",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250529",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake."
},
{
"NDCCode": "0480-7066-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-7066-56) ",
"NDC11Code": "00480-7066-56",
"ProductNDC": "0480-7066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209801",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250529",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake."
},
{
"NDCCode": "0480-7067-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-7067-56) ",
"NDC11Code": "00480-7067-56",
"ProductNDC": "0480-7067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209801",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250529",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake."
},
{
"NDCCode": "0480-7068-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-7068-56) ",
"NDC11Code": "00480-7068-56",
"ProductNDC": "0480-7068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209801",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250529",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake."
},
{
"NDCCode": "0781-3416-94",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94) / 20 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00781-3416-94",
"ProductNDC": "0781-3416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090862",
"LabelerName": "Sandoz Inc",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120530",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole for injection is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "Voriconazole, an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. Voriconazole for injection is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 25 mL Type I clear glass vial. Voriconazole for injection is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL voriconazole and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)]."
},
{
"NDCCode": "10812-349-01",
"PackageDescription": "3.4 g in 1 TUBE (10812-349-01) ",
"NDC11Code": "10812-0349-01",
"ProductNDC": "10812-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Moistureshine Spf20",
"ProprietaryNameSuffix": "Coral Dream 500",
"NonProprietaryName": "Octinoxate, Octisalate, And Titanium Dioxide",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100215",
"EndMarketingDate": "20231201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "50; 25; 11",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100215",
"EndMarketingDatePackage": "20231201",
"SamplePackage": "N"
},
{
"NDCCode": "14141-349-01",
"PackageDescription": "1 TUBE in 1 CARTON (14141-349-01) / 3 g in 1 TUBE",
"NDC11Code": "14141-0349-01",
"ProductNDC": "14141-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cyzone Cy Play Creamy Lip Balm Hidratante En Barra Para Labios 24h Fps 12 Cherry Creamy",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240912",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BEL STAR S A",
"SubstanceName": "ZINC OXIDE; OCTINOXATE",
"StrengthNumber": "39.2; 25",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240912",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "21695-349-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (21695-349-30)",
"NDC11Code": "21695-0349-30",
"ProductNDC": "21695-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain. 50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "21695-349-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (21695-349-60)",
"NDC11Code": "21695-0349-60",
"ProductNDC": "21695-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain. 50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "30142-349-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (30142-349-01) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "30142-0349-01",
"ProductNDC": "30142-349",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kroger Eye Drops Seasonal Relief",
"NonProprietaryName": "Tetrahydrozoline Hcl, Zinc Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20230323",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Kroger",
"SubstanceName": "TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE",
"StrengthNumber": ".05; .25",
"StrengthUnit": "g/100mL; g/100mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230323",
"SamplePackage": "N",
"IndicationAndUsage": "Use: 1 for temporary relief of discomfort and redness of the eye due to minor eye irritation."
},
{
"NDCCode": "33261-349-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (33261-349-10)",
"NDC11Code": "33261-0349-10",
"ProductNDC": "33261-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077877",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Atenolol tablets, USP are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.",
"Description": "Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C14H22N2O3 and its structural formula is:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37° C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25° C) and less soluble in chloroform (3 mg/mL at 25° C). Atenolol tablets, USP are available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate."
},
{
"NDCCode": "33261-349-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (33261-349-30)",
"NDC11Code": "33261-0349-30",
"ProductNDC": "33261-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077877",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Atenolol tablets, USP are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.",
"Description": "Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C14H22N2O3 and its structural formula is:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37° C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25° C) and less soluble in chloroform (3 mg/mL at 25° C). Atenolol tablets, USP are available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate."
},
{
"NDCCode": "33261-349-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (33261-349-60)",
"NDC11Code": "33261-0349-60",
"ProductNDC": "33261-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077877",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Atenolol tablets, USP are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.",
"Description": "Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C14H22N2O3 and its structural formula is:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37° C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25° C) and less soluble in chloroform (3 mg/mL at 25° C). Atenolol tablets, USP are available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate."
},
{
"NDCCode": "43063-349-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-349-15) ",
"NDC11Code": "43063-0349-15",
"ProductNDC": "43063-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Ibuprofen",
"NonProprietaryName": "Hydrocodone Bitartrate And Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076604",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; IBUPROFEN",
"StrengthNumber": "7.5; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170127",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>65923-349-25</NDCCode>
<PackageDescription>25 PACKET in 1 CARTON (65923-349-25) > 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>65923-0349-25</NDC11Code>
<ProductNDC>65923-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uec Medical Insect Sting Relief</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol, And Benzocaine</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160425</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>BENZOCAINE; ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.06; .7</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65923-349-10</NDCCode>
<PackageDescription>100 PACKET in 1 CARTON (65923-349-10) > 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>65923-0349-10</NDC11Code>
<ProductNDC>65923-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uec Medical Insect Sting Relief</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol, And Benzocaine</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160425</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>BENZOCAINE; ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.06; .7</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65923-136-25</NDCCode>
<PackageDescription>20 mg in 1 POUCH (65923-136-25)</PackageDescription>
<NDC11Code>65923-0136-25</NDC11Code>
<ProductNDC>65923-136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nu Pore Acne</ProprietaryName>
<NonProprietaryName>Salicyilc Acid</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131204</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/100mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>65923-345-25</NDCCode>
<PackageDescription>25 POUCH in 1 BOX (65923-345-25) > 3 g in 1 POUCH</PackageDescription>
<NDC11Code>65923-0345-25</NDC11Code>
<ProductNDC>65923-345</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uec Medical Bzk Antiseptic Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 clean the affected area, 2 apply a small amount of this product on the area 1 to 3 times daily, 3 may be covered with sterile bandage, 4 if bandaged let dry first.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65923-584-25</NDCCode>
<PackageDescription>30 VIAL, SINGLE-USE in 1 BOX (65923-584-25) > .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>65923-0584-25</NDC11Code>
<ProductNDC>65923-584</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Care Single-use Eye</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 400, And Propylene Glycol</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20160328</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>4; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12546-349-25</NDCCode>
<PackageDescription>25 LOZENGE in 1 PACKAGE (12546-349-25) </PackageDescription>
<NDC11Code>12546-0349-25</NDC11Code>
<ProductNDC>12546-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Halls</ProprietaryName>
<ProprietaryNameSuffix>Sugar Free Mentho-lyptus</ProprietaryNameSuffix>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Mondelez Global LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>2.7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61703-349-36</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61703-349-36) / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>61703-0349-36</NDC11Code>
<ProductNDC>61703-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irinotecan Hydrochloride</ProprietaryName>
<NonProprietaryName>Irinotecan Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077915</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Irinotecan Hydrochloride Injection, USP is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan Hydrochloride Injection, USP is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.</IndicationAndUsage>
<Description>Irinotecan Hydrochloride Injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan Hydrochloride Injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP and Water for Injection, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan Hydrochloride Injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. The chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate. Its empirical formula is C33H38N4O6∙HCl∙3H2O and molecular weight is 677.19. It is slightly soluble in water and organic solvents. Its structural formula is as follows.</Description>
</NDC>
<NDC>
<NDCCode>62157-349-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62157-349-01)</PackageDescription>
<NDC11Code>62157-0349-01</NDC11Code>
<ProductNDC>62157-349</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mebendazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20161012</StartMarketingDate>
<EndMarketingDate>20170804</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>AX Pharmaceutical Corp</LabelerName>
<SubstanceName>MEBENDAZOLE</SubstanceName>
<StrengthNumber>24.75</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20170804</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63323-349-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-25) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-01) </PackageDescription>
<NDC11Code>63323-0349-25</NDC11Code>
<ProductNDC>63323-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipenem And Cilastatin</ProprietaryName>
<NonProprietaryName>Imipenem And Cilastatin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090577</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>IMIPENEM; CILASTATIN SODIUM</SubstanceName>
<StrengthNumber>250; 250</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: : 1 Lower respiratory tract infections. ( 1.1) , 2 Urinary tract infections. ( 1.2) , 3 Intra-abdominal infections. ( 1.3) , 4 Gynecologic infections. ( 1.4) , 5 Bacterial septicemia. ( 1.5) , 6 Bone and joint infections. ( 1.6) , 7 Skin and skin structure infections. ( 1.7) , 8 Endocarditis. ( 1.8) .</IndicationAndUsage>
<Description>Imipenem and Cilastatin for Injection, USP (I.V.) (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP (I.V.) is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C12H17N3O4SH2O, and its structural formula is:. Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z)-7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is. Imipenem and Cilastatin for Injection, USP (I.V.) is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. [see How Supplied/ Storage and Handling ( 16.1).] Each Imipenem and Cilastatin for Injection, USP (I.V.) 250 mg/250 mg vial contains imipenem USP 250 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 250 mg cilastatin and each 500 mg/500 mg vial contains imipenem USP 500 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 500 mg cilastatin. In addition, the 250 mg/250 mg vial contains 10 mg of sodium bicarbonate and the 500 mg/500 mg vial contains 20 mg of sodium bicarbonate. The sodium content of the 250 mg/250 mg vial is 18.8 mg (0.8 mEq) and the sodium content for the 500 mg/500 mg vial is 37.5 mg (1.6 mEq). Solutions of Imipenem and Cilastatin for Injection, USP (I.V.) range from colorless to yellow. Variations of color within this range do not affect the potency of the product.</Description>
</NDC>
<NDC>
<NDCCode>63323-349-93</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-93) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-21) </PackageDescription>
<NDC11Code>63323-0349-93</NDC11Code>
<ProductNDC>63323-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipenem And Cilastatin</ProprietaryName>
<NonProprietaryName>Imipenem And Cilastatin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090577</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>IMIPENEM; CILASTATIN SODIUM</SubstanceName>
<StrengthNumber>250; 250</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: : 1 Lower respiratory tract infections. ( 1.1) , 2 Urinary tract infections. ( 1.2) , 3 Intra-abdominal infections. ( 1.3) , 4 Gynecologic infections. ( 1.4) , 5 Bacterial septicemia. ( 1.5) , 6 Bone and joint infections. ( 1.6) , 7 Skin and skin structure infections. ( 1.7) , 8 Endocarditis. ( 1.8) .</IndicationAndUsage>
<Description>Imipenem and Cilastatin for Injection, USP (I.V.) (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP (I.V.) is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C 12H 17N 3O 4SH 2O, and its structural formula is:. Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z)-7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C 16H 25N 2O 5SNa, and its structural formula is:. Imipenem and Cilastatin for Injection, USP (I.V.) is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. [see How Supplied/ Storage and Handling ( 16.1).] Each Imipenem and Cilastatin for Injection, USP (I.V.) 250 mg/250 mg vial contains imipenem USP 250 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 250 mg cilastatin and each 500 mg/500 mg vial contains imipenem USP 500 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 500 mg cilastatin. In addition, the 250 mg/250 mg vial contains 10 mg of sodium bicarbonate and the 500 mg/500 mg vial contains 20 mg of sodium bicarbonate. The sodium content of the 250 mg/250 mg vial is 18.8 mg (0.8 mEq) and the sodium content for the 500 mg/500 mg vial is 37.5 mg (1.6 mEq). Solutions of Imipenem and Cilastatin for Injection, USP (I.V.) range from colorless to yellow. Variations of color within this range do not affect the potency of the product.</Description>
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<ApplicationNumber>ANDA090577</ApplicationNumber>
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<StrengthUnit>mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
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<StartMarketingDatePackage>20120103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: : 1 Lower respiratory tract infections. ( 1.1) , 2 Urinary tract infections. ( 1.2) , 3 Intra-abdominal infections. ( 1.3) , 4 Gynecologic infections. ( 1.4) , 5 Bacterial septicemia. ( 1.5) , 6 Bone and joint infections. ( 1.6) , 7 Skin and skin structure infections. ( 1.7) , 8 Endocarditis. ( 1.8) .</IndicationAndUsage>
<Description>Imipenem and Cilastatin for Injection, USP (I.V.) (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP (I.V.) is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C12H17N3O4SH2O, and its structural formula is:. Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z)-7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is:. Imipenem and Cilastatin for Injection, USP (I.V.) is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. [see How Supplied/ Storage and Handling ( 16.1).] Each Imipenem and Cilastatin for Injection, USP (I.V.) 250 mg/250 mg vial contains imipenem USP 250 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 250 mg cilastatin and each 500 mg/500 mg vial contains imipenem USP 500 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 500 mg cilastatin. In addition, the 250 mg/250 mg vial contains 10 mg of sodium bicarbonate and the 500 mg/500 mg vial contains 20 mg of sodium bicarbonate. The sodium content of the 250 mg/250 mg vial is 18.8 mg (0.8 mEq) and the sodium content for the 500 mg/500 mg vial is 37.5 mg (1.6 mEq). Solutions of Imipenem and Cilastatin for Injection, USP (I.V.) range from colorless to yellow. Variations of color within this range do not affect the potency of the product.</Description>
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<NDC>
<NDCCode>75839-349-99</NDCCode>
<PackageDescription>25 kg in 1 DRUM (75839-349-99)</PackageDescription>
<NDC11Code>75839-0349-99</NDC11Code>
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<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Enrofloxacin Hcl</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>ENROFLOXACIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>kg/5kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65923-005-54</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (65923-005-54) > 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>65923-0005-54</NDC11Code>
<ProductNDC>65923-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Care Childrens Decongestant Nose Drops</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20120110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>UNITED EXCHANGE CORP</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions (Nasal use only): 1 children 2 to under 6 years (with adult supervision): 2 to 3 drops into each nostril, not more often than every 4 hours , 2 children under 2 years of age: Consult a physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65923-144-57</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (65923-144-57) / 57 g in 1 TUBE</PackageDescription>
<NDC11Code>65923-0144-57</NDC11Code>
<ProductNDC>65923-144</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Care Muscle And Joint</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 use only as directed, 2 adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily, 3 children under 12 years of age: ask a doctor.</IndicationAndUsage>
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<NDC>
<NDCCode>0480-7062-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-7062-56) </PackageDescription>
<NDC11Code>00480-7062-56</NDC11Code>
<ProductNDC>0480-7062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209801</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0480-7063-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-7063-56) </PackageDescription>
<NDC11Code>00480-7063-56</NDC11Code>
<ProductNDC>0480-7063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209801</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0480-7065-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-7065-56) </PackageDescription>
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<ProductNDC>0480-7065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<StartMarketingDate>20250529</StartMarketingDate>
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<ApplicationNumber>ANDA209801</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake.</Description>
</NDC>
<NDC>
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<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-7066-56) </PackageDescription>
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<ProductNDC>0480-7066</ProductNDC>
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<StartMarketingDate>20250529</StartMarketingDate>
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<ApplicationNumber>ANDA209801</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake.</Description>
</NDC>
<NDC>
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<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-7067-56) </PackageDescription>
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<ProductNDC>0480-7067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209801</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0480-7068-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-7068-56) </PackageDescription>
<NDC11Code>00480-7068-56</NDC11Code>
<ProductNDC>0480-7068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209801</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile. The molecular formula is C23H15N3O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is. Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-3416-94</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94) / 20 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00781-3416-94</NDC11Code>
<ProductNDC>0781-3416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090862</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole for injection is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. Voriconazole for injection is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 25 mL Type I clear glass vial. Voriconazole for injection is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL voriconazole and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)].</Description>
</NDC>
<NDC>
<NDCCode>10812-349-01</NDCCode>
<PackageDescription>3.4 g in 1 TUBE (10812-349-01) </PackageDescription>
<NDC11Code>10812-0349-01</NDC11Code>
<ProductNDC>10812-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Moistureshine Spf20</ProprietaryName>
<ProprietaryNameSuffix>Coral Dream 500</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100215</StartMarketingDate>
<EndMarketingDate>20231201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>50; 25; 11</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100215</StartMarketingDatePackage>
<EndMarketingDatePackage>20231201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14141-349-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (14141-349-01) / 3 g in 1 TUBE</PackageDescription>
<NDC11Code>14141-0349-01</NDC11Code>
<ProductNDC>14141-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cyzone Cy Play Creamy Lip Balm Hidratante En Barra Para Labios 24h Fps 12 Cherry Creamy</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240912</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BEL STAR S A</LabelerName>
<SubstanceName>ZINC OXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>39.2; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-349-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (21695-349-30)</PackageDescription>
<NDC11Code>21695-0349-30</NDC11Code>
<ProductNDC>21695-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain. 50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>21695-349-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (21695-349-60)</PackageDescription>
<NDC11Code>21695-0349-60</NDC11Code>
<ProductNDC>21695-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain. 50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>30142-349-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (30142-349-01) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>30142-0349-01</NDC11Code>
<ProductNDC>30142-349</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kroger Eye Drops Seasonal Relief</ProprietaryName>
<NonProprietaryName>Tetrahydrozoline Hcl, Zinc Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20230323</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Kroger</LabelerName>
<SubstanceName>TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE</SubstanceName>
<StrengthNumber>.05; .25</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use: 1 for temporary relief of discomfort and redness of the eye due to minor eye irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33261-349-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (33261-349-10)</PackageDescription>
<NDC11Code>33261-0349-10</NDC11Code>
<ProductNDC>33261-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077877</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol tablets, USP are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C14H22N2O3 and its structural formula is:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37° C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25° C) and less soluble in chloroform (3 mg/mL at 25° C). Atenolol tablets, USP are available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>33261-349-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (33261-349-30)</PackageDescription>
<NDC11Code>33261-0349-30</NDC11Code>
<ProductNDC>33261-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077877</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol tablets, USP are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C14H22N2O3 and its structural formula is:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37° C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25° C) and less soluble in chloroform (3 mg/mL at 25° C). Atenolol tablets, USP are available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>33261-349-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (33261-349-60)</PackageDescription>
<NDC11Code>33261-0349-60</NDC11Code>
<ProductNDC>33261-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077877</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol tablets, USP are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C14H22N2O3 and its structural formula is:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37° C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25° C) and less soluble in chloroform (3 mg/mL at 25° C). Atenolol tablets, USP are available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>43063-349-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-349-15) </PackageDescription>
<NDC11Code>43063-0349-15</NDC11Code>
<ProductNDC>43063-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Ibuprofen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076604</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; IBUPROFEN</SubstanceName>
<StrengthNumber>7.5; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>